Pain Management for CIED Implants
This study is looking at ways to reduce pain after getting a cardiac implantable electronic device (CIED), like a pacemaker. Researchers are comparing a combination of three medications—Bupivacaine, Ketorolac, and Ketamine (BKK)—to Bupivacaine alone. Bupivacaine is a common numbing medicine. Ketorolac is for pain relief, and Ketamine can also help with pain and sedation. The goal is to see if the BKK combination is better at reducing pain, improving comfort, and enhancing your quality of life in the week after surgery. You may be able to join if you are over 18, having a new CIED implanted, and are willing to participate. You cannot join if you are allergic to any of the study drugs, are pregnant or breastfeeding, or are a prisoner. The study aims to enroll 200 participants, but its current status is unclear.
- Study design
- This interventional study will compare two groups: one receiving Bupivacaine alone and another receiving a Bupivacaine-Ketorolac-Ketamine combination. It plans to enroll 200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 1 week after treatment to assess pain, comfort, and quality of life.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Dhanunjaya Lakkireddy, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensityUpto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity. Patient's pain will be assessed using a Visual Analog Scale either through a telephone call from the research team or via clinic follow-up visit. The visual analog scale (VAS) determines pain from 0 to 10 with 0 indicating no pain (Better outcome) and 10 indicating worse pain in their life indicating (worse outcome).
- Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfortUpto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort. Patient's comfort will be assessed using a verbal rating score either through a telephone call from the research team or via clinic follow-up visit. The comfort score determines patients comfort from 0 to 100 with 0 indicating extremely uncomfortable (Worse outcome) and 100 indicating extremely comfortable (Better outcome).
- Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL)Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life. Patient's Quality of Life will be assessed using a QoL score (EQ5-5D-5L) either through a telephone call from the research team or via clinic follow-up visit. The Quality of life questionnaire (EQ-5D-5L) has five response levels : no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5), with low values suggesting better outcomes and higher values suggesting worse outcomes.